AB0958 A STUDY ON EARLY TAPERING OF TOFACITINIB IN ANKYLOSING SPONDYLITIS: A HIT AND RUN STRATEGY
Authors: V. Viswanath, H. Sreekumar, L. Sreekumari Ramachandran, A. G. Varier
Journal: Annals of the Rheumatic Diseases (2023)

<h3>Background</h3> <b>Tofacitinib is emerging as a cost-effective drug in managing ankylosing spondylitis (AS</b>) <sup><b>[1].</b></sup><b>Tofacitinib (XELJANZ) was FDA-approved for the use of active AS in December 2021. Safety concerns have been raised about the long-term use of Tofacitinib following the ORAL surveillance trial data</b><sup><b>[2].</b></sup><b>However, in developing countries, the cost is a primary concern, and Tofacitinib, an oral drug, can be considered an alternative to biologicals. This study investigates whether early tapering can mitigate the safety risk and attain sustained remission.</b> <h3>Objectives</h3> <b>To assess the efficacy of early tapering of tofacitinib on disease activity in adult patients with active AS.</b> <h3>Methods</h3> <b>This observational study enrolled 22 consecutive patients aged ≥18 years diagnosed with active AS, meeting the ASAS criteria</b><sup><b>[3].</b></sup><b>Patients received tofacitinib 10mg per day. ASDAS CRP was calculated at 0 and 6 months to monitor the response. The primary and secondary endpoints were early tapering of tofacitinib within six months of initiation and assessment of ASDAS CRP at six months, respectively. Assessment of the safety profile was done monthly.</b> <h3>Results</h3> <b>In our study, the mean ASDAS CRP at the initiation of tofacitinib was 2.24 (SD 1.13). After six months of treatment, the mean ASDAS CRP was 0.9 (SD 0.6), with remission in 77.27% (17 of 22). Tapering was initiated at a mean of 4.4 months (SD 3.18) and as early as one month. 41%of patients (9 of 22) had attained remission with early tapering of Tofacitinib and in 9%of patients (2 of 22), we could successfully stop Tofacitinib with sustained remission. Transaminitis occurred in 22% (5 of 22), of which in 2 patients drug had to be stopped.Two2 patients (9%) had to be switched to biologicals due to non-responsiveness. There were no deaths, malignancies, major adverse cardiovascular events, thromboembolic events, or opportunistic infections.</b> <h3>Conclusion</h3> <b>In our study of 22 patients, we find that Tofacitinib can be a cost-effective treatment option in patients with AS who cannot afford biologicals, especially in a developing economy like India. However, recent concerns about the drug's long-term safety preclude its optimal use. Early tapering of Tofacitinib demonstrates no increased incidence of flares and helps maintain remission. A hit-and-run strategy of early tapering of Tofacitinib would benefit patients with AS in the Indian context. We find that early tapering is effective in at least some of the patients, and it can reduce the cost of treatment as well as potential adverse reactions</b>. <h3>References</h3> [1]<b>Deodhar A, Sliwinska-Stanczyk P, Xu H, Baraliakos X, Gensler LS, Fleishaker D, Wang L, Wu J, Menon S, Wang C, Dina O. Tofacitinib for the treatment of ankylosing spondylitis: a phase III, randomized, double-blind, placebo-controlled study. Annals of the rheumatic diseases. 2021 Aug 1;80(8):1004-13.</b> [2]<b>Ytterberg SR, Bhatt DL, Mikuls TR, Koch GG, Fleischmann R, Rivas JL, Germino R, Menon S, Sun Y, Wang C, Shapiro AB. Cardiovascular and cancer risk with tofacitinib in rheumatoid arthritis. New England Journal of Medicine. 2022 Jan 27;386(4):316-26.</b> [3]<b>Rudwaleit M, Van Der Heijde D, Landewé R, Listing J, Akkoc N, Brandt J, Braun J, Chou CT, Collantes-Estevez E, Dougados M, Huang F. The development of Assessment of SpondyloArthritis international Society classification criteria for axial spondyloarthritis (part II): validation and final selection. Annals of the rheumatic diseases. 2009 Jun 1;68(6):777-83</b> <h3>Acknowledgements:</h3> NIL. <h3>Disclosure of Interests</h3> None Declared.